Lumasiran,
does it really help with Reduction in 24-hour urinary oxalate in primary hyperoxaluria type 1?
research showsGrade C. At six months, placebo-adjusted change from baseline in 24-hour urinary oxalate was -53.5 percentage points (95% CI -62.3 to -44.8). This is a laboratory surrogate and does not establish fewer kidney failures or stones in this trial.
ads claimThis six-month trial lowered urinary oxalate but did not answer whether kidney failure, dialysis, transplantation, or kidney-stone events were reduced.
Useful facts when choosing a product
- Lumasiran is a subcutaneous siRNA targeting HAO1 mRNA.
- Verdict 2866 is C with 50 points for zilebesiran and verdict 2865 is C with 50 points for givosiran; they share the siRNA class but address different targets and diseases.
- Korean Oxlumo authorization and reimbursement could not be confirmed in publicly accessible sources as of 2026-08-26.
What the research actually shows
No defect. The source reports 39 randomized participants in an ultra-rare genetic disease, for which enrollment of 200 was not realistically possible, so small size was not counted as a defect. The four requirements are documented in the source as 'double-blind', 'placebo-controlled', 'modified intention-to-treat population', and 'prespecified primary end point': masking, placebo control, assigned-group analysis, and a preregistered primary endpoint. No other listed defect applies. Alnylam Pharmaceuticals funded the trial.
Why this is classified as C (54)
A large laboratory change remains one 39-person manufacturer-sponsored surrogate study, but no listed design defect applies, giving C, 54.
Counterpoint. Injection-site reactions occurred in 38% versus 0%.
Rejudgment record. Source checked — A 39-person double-blind placebo-controlled trial measuring 24-hour urinary oxalate
| Endpoint | S | Surrogate marker - laboratory or imaging measures |
| Replication | R1 | Single confirmatory trial |
| Independence | I0 | Evidence comes only from manufacturer studies |
| Effect size | E+ | Meets the clinically important threshold |
The scoring table and the verdict agree (C).
Sub-claim grades by effect
This ingredient is marketed for several effects. A single overall grade blends strong and weak claims together, so each effect is graded separately here. The overall grade reflects the strongest disconfirming or core claim.
| Effect (sub-claim) | Grade | Basis |
|---|---|---|
| Reduction in 24-hour urinary oxalate | C | The change is large but surrogate. |
| Reduction in kidney failure or stones | ? | The six-month controlled trial did not answer this. |
Cross-check — AI research and Codex final gate
Evidence Table
| Study | Design | Sample | Funding | Endpoint | Result | Weight |
|---|---|---|---|---|---|---|
| ILLUMINATE-A 2021 | Phase 3 double-blind placebo-controlled randomized trial | 13 | Alnylam Pharmaceuticals | Percent change from baseline in 24-hour urinary oxalate excretion through month 6 | Placebo-adjusted least-squares mean difference -53.5 percentage points (95% CI -62.3 to -44.8) | Pivotal surrogate evidence |
Receipt — 1 References
All 1 cited sources were verified for existence at the original page (as of 2026-08-26).
Final verification and publication gate: Codex · Verification cutoff: 2026-08-26 · Corrections: none
Cite this verdict
[Chamgap] Benefit of Lumasiran for Urinary Oxalate Reduction in Primary Hyperoxaluria Type 1, a Surrogate Outcome — Evidence Grade C·54. 1 cited sources checked. Source: https://chamgap.com/en/verdicts/general/lumasiran-primary-hyperoxaluria-type-1-urinary-oxalate-reduction/ · CC BY 4.0CC BY 4.0 — free to use with attribution; do not distort grades, numbers, or verdict meaning.
What this document does and does not do
Chamgap is an information source. It reports what research has and has not confirmed; it does not tell readers what to take or buy. That decision belongs to readers and, when needed, medical or legal professionals. This verdict reflects literature available up to the search date and may change as new research appears. Nothing here is medical advice.